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RESEARCH ETHICS: How Practical Are Helsinki Rules?

Yale University's Dr. Robert Levine and Harvard Medical School's Dr. Troyen Brennan debate the efficacy of the Declaration of Helsinki rules, which mandate that human volunteers in clinical trials "receive the best medical care available," in yesterday's New England Journal of Medicine, Reuters/Nando Times reports. The rules followed complaints from Public Citizen's Drs. Sidney Wolfe and Peter Lurie in 1997, alleging they "had identified 15 government-financed studies, all done in developing countries, that used unethical methods to test if various treatments can block the spread of the AIDS virus from a woman to her newborn child." Currently, the World Medical Association is debating whether to change the rules to permit scientists to offer test subjects no treatment "or a worthless one if that is what the volunteers would normally receive in their country" (Emery, Reuters/Nando Times, 8/11).

From the Ivory Tower According to Brennan, "[A]ny changes we make in the ethical principles of research, such as the proposed revisions to the Declaration of Helsinki, will affect all research, not just studies of the perinatal transmission of HIV. By undermining the protection of individual rights, the just allocation of the burdens and benefits of research, and most ominously, the investigator's moral duty to the research subject, the proposed revisions would substantially change the ethical boundaries of research." Brennan concludes, "The declaration has served us well, protecting vulnerable populations yet allowing research to proceed" (Brennan, NEJM, 8/12 issue). However, Levine notes that the "prolonged oral administration of zidovudine to a pregnant HIV-infected woman, intravenous administration of zidovudine during delivery and oral administration of the drug to the newborn infant" is unsustainable in the developing world, as it carries a $800-per-patient price tag. He also notes that long-term treatment was not implemented as women in the communities where the trials were held seek prenatal care "late in their pregnancies," the local clinics lacked the equipment to administer the regimen intravenously, and the community lacked a safe water supply in order to provide the treatment to infants. Levine concludes, "Interpretations of ethical codes and guidelines that force sponsors and investigators to distort their research protocols so that they are unresponsive to the needs of developing countries are detrimental to the interests of all concerned" (Levine, NEJM, 8/12 issue).

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